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Monoclonal Antibodies
Sapanisertib + Bevacizumab for Glioblastoma
Phase 1
Waitlist Available
Led By Lakshmi Nayak
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have a histologically/cytologically confirmed diagnosis of recurrent glioblastoma or an advanced solid tumor in which bevacizumab has shown benefit
Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study Summary
This trial is studying the side effects and best dose of the TORC1/2 inhibitor MLN0128 when given in combination with bevacizumab in treating patients with glioblastoma or other solid tumors.
Who is the study for?
This trial is for adults with recurrent glioblastoma or advanced solid tumors that haven't responded to standard treatments. Participants must be able to swallow capsules, have no other concurrent cancers (except certain skin cancers), and use contraception if of child-bearing potential. They should not be on corticosteroids, pregnant, nursing, or have significant allergies to the drugs being tested.Check my eligibility
What is being tested?
The trial is testing a combination of TORC1/2 inhibitor MLN0128 and monoclonal antibody Bevacizumab in patients with specific types of brain and solid tumors. It aims to find the safest dose while assessing how these drugs might block tumor growth by inhibiting enzymes needed for cell growth and blood vessel formation.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system suppression such as increased risk of infection, high blood pressure issues, gastrointestinal disturbances which could affect drug absorption, allergic reactions similar in nature to those from compounds like MLN0128 or Bevacizumab.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a confirmed diagnosis of recurrent glioblastoma or an advanced cancer treatable with bevacizumab.
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I have no other cancers except possibly treated skin cancer.
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I can take care of myself but might not be able to do heavy physical work.
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I am not currently taking corticosteroids.
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I can swallow whole capsules.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (R2PD) of Daily Oral MLN0128 When Administered With Bevacizumab
Most Common Related Toxicities That Led to Dose Hold/Reductions
Secondary outcome measures
Number of Participants Who Had an MLN0128 Dose-Reduction On Study
Number of Participants With Toxicities Leading to Missed Doses or Delays
Number of Patients That Discontinue Study Drugs Due to Treatment Related Toxicity
+3 moreOther outcome measures
Cerebrospinal Fluid (CSF) Penetration of TORC1/2 Inhibitor MLN0128, Evaluated Using Plasma and CSF Pharmacokinetic (PK) Parameters of MLN0128
Change in Circulating Plasma Levels of Angiogenic Growth Factors in Patients With Ovarian and Endometrial Cancers
Change in Phosphorylated Proteins Within Tumor Biopsies From Patients With Ovarian and Endometrial Cancers
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (TORC1/2 inhibitor INK128, bevacizumab)Experimental Treatment4 Interventions
Patients receive TORC1/2 inhibitor INK128 PO QD on days 1-28 and bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Sapanisertib
2016
Completed Phase 2
~840
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,659 Previous Clinical Trials
40,924,639 Total Patients Enrolled
Lakshmi NayakPrincipal InvestigatorDana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a stomach or intestine problem that affects how I absorb pills.I haven't used specific growth factors recently.I do not have uncontrolled high blood pressure, asthma, or diabetes.I do not have any major heart, lung, stomach, blood, hormone, kidney, liver, or infectious diseases.Your blood and body chemistry need to be within certain limits.My heart health meets the study's requirements.I have a confirmed diagnosis of recurrent glioblastoma or an advanced cancer treatable with bevacizumab.I have no other cancers except possibly treated skin cancer.I am HIV-positive and on combination antiretroviral therapy.I have had many treatments for my cancer and it has come back each time.I can take care of myself but might not be able to do heavy physical work.I can provide tissue samples or have a lesion that can be biopsied.I am not currently taking corticosteroids.I can swallow whole capsules.I have recovered from major side effects of my previous treatments.I am not taking any specific medications or herbal supplements.Your disease can be measured or evaluated using specific standards.I have allergies to drugs similar to MLN0128 or bevacizumab.I have not received any treatments that are excluded for my group.I agree to use birth control during the study.I have brain metastases that are causing symptoms or getting bigger.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (TORC1/2 inhibitor INK128, bevacizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there other research programs using Bevacizumab?
"At present, there are 365 Bevacizumab-related clinical trials being conducted worldwide, with 89 of those in Phase 3. Specifically, Taipei City is running many of these studies; however, the total number of sites participating reaches 18952."
Answered by AI
How many participants have been recruited to partake in this clinical investigation?
"As of the last update on June 28th 2022, this particular research project is not recruiting patients. If you are in seek of an alternative trial, there are currently 4676 studies for malignant neoplasm of ovary and 365 clinical trials involving bevacizumab that actively require participants."
Answered by AI
Are there any available vacancies in this clinical trial?
"This medical trial is not accepting applicants at this time. It was first uploaded to clinicaltrials.gov on May 20th 2014 and has been updated as recently as June 28th 2022. For those looking for alternative studies, there are presently 4676 trials recruiting participants with malignant neoplasm of ovary and 365 seeking patients that would like to use Bevacizumab as a treatment option."
Answered by AI
What is the regulatory status of Bevacizumab?
"As this is a phase 1 clinical trial, there is limited data that supports the safety and efficacy of bevacizumab, so it was rated as score of 1."
Answered by AI
To what conditions is Bevacizumab commonly prescribed?
"Bevacizumab is a viable treatment option for recurrent platinum-sensitive primary peritoneal cancer, stage IV epithelial ovarian cancer after initial surgery, and malignant neoplasms."
Answered by AI
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